U.S. patent number 7,559,452 [Application Number 11/165,094] was granted by the patent office on 2009-07-14 for surgical instrument having fluid actuated opposing jaws.
This patent grant is currently assigned to Ethicon Endo-Surgery, Inc.. Invention is credited to Frederick E. Shelton, IV, Kenneth S. Wales.
United States Patent |
7,559,452 |
Wales , et al. |
July 14, 2009 |
Surgical instrument having fluid actuated opposing jaws
Abstract
A surgical stapling and severing instrument enables minimally
invasive surgical procedures by having upper and lower jaws (i.e.,
anvil and staple channel) that are positioned with an elongate
shaft and handle through surgical openings, and in particular
through a cannula of a trocar. A pair of fluid actuator bladders
(lift bags) are positioned in the staple channel beneath a
proximally projecting lever tray so that transfer of fluid from the
handle causes closing and clamping of the anvil. The bi-directional
fluid control may be mechanically produced at the handle or by
activating an electroactive polymer actuator. Once firing is
sensed, an EAP plunger in a medical substance syringe inserted into
the elongate shaft is activated to dispense a medical substance
(e.g., anesthetics, adhesives, cauterizing substances, antibiotics,
etc.) and is guided along a firing bar to a cutting surface of an
E-beam placing the substance on tissue as severed.
Inventors: |
Wales; Kenneth S. (Mason,
OH), Shelton, IV; Frederick E. (Hillsboro, OH) |
Assignee: |
Ethicon Endo-Surgery, Inc.
(Cincinnati, OH)
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Family
ID: |
36691808 |
Appl.
No.: |
11/165,094 |
Filed: |
June 23, 2005 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20060289600 A1 |
Dec 28, 2006 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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11061908 |
Feb 18, 2005 |
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Current U.S.
Class: |
227/176.1;
227/175.1; 227/180.1; 227/19 |
Current CPC
Class: |
A61B
17/068 (20130101); A61B 17/07207 (20130101); A61B
17/115 (20130101); A61B 17/29 (20130101); A61B
17/320016 (20130101); A61B 17/3201 (20130101); A61B
17/00491 (20130101); A61B 2017/00539 (20130101); A61B
2017/00544 (20130101); A61B 2017/00893 (20130101); A61B
2017/07214 (20130101); A61B 2017/07285 (20130101); A61B
2017/2912 (20130101); A61B 2017/2932 (20130101) |
Current International
Class: |
A61B
17/072 (20060101); A61B 17/068 (20060101) |
Field of
Search: |
;227/178.1,180.1,182.1,19,176.1 ;606/219 |
References Cited
[Referenced By]
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Primary Examiner: Rada; Rinaldi I.
Assistant Examiner: Low; Lindsay
Attorney, Agent or Firm: Frost Brown Todd LLC
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATIONS
This application is a continuation-in-part of commonly owned U.S.
patent application Ser. No. 11/061,908 entitled "SURGICAL
INSTRUMENT INCORPORATING A FLUID TRANSFER CONTROLLED ARTICULATION
MECHANISM" to Kenneth Wales and Chad Boudreaux, filed on Feb. 18,
2005, now abandoned, the disclosure of which is hereby incorporated
by reference in its entirety.
Claims
What is claimed is:
1. A surgical instrument, comprising: a handle operably configured
to produce closure actuation and opening actuation; an elongate
shaft attached to the handle and defining a longitudinal axis; an
end effector distally attached to the elongate shaft and comprising
a pair of pivoting members opposingly contacting tissue, wherein
the lower pivoting member comprises a staple channel and the upper
pivoting member comprises an anvil, and each pivoting member
including a respective proximally projecting lever constrained to
pivot relative to the other lever about a pivot connection, wherein
the lever projecting proximally from the staple channel comprises a
frame of the elongate shaft attached to the handle and the lever
projecting proximally from the anvil comprises an anvil lever; a
staple cartridge received in the staple channel; a firing bar
slidingly received in the elongate channel and distally movable
through the closed end effector to effect severing and stapling of
clamped tissue; an outer sheath encompassing the frame of the
elongate shaft and the lever of the anvil; and a fluid actuated
closure mechanism comprising: a fluid actuator bladder positioned
between the levers proximal to the pivot connection to operably
engage with one or more of the respective proximal projecting
levers of the pair of pivoting members, a fluid conduit
communicating fluid with the fluid actuator bladder and extending
through the elongate shaft, a fluid reservoir responsive to the
closure actuation by the handle to selectively and bi-directionally
transfer fluid across the fluid conduit to move at least a portion
of the fluid actuator bladder laterally to the longitudinal axis to
close and open the end effector, and an opposing fluid actuator
bladder positioned between the anvil lever and the outer sheath for
opposing the fluid actuator positioned between the proximal
projecting levers to close the anvil, the handle further
operatively configured to differentially expand and compress the
opposing fluid actuator bladder and the fluid actuator bladder to
move the anvil open and closed.
2. The surgical instrument of claim 1, wherein the handle is
operably configured to produce a reciprocating mechanical closure
motion, the fluid reservoir selectively compressed and expanded by
the reciprocating mechanical closure motion.
3. The surgical instrument of claim 1, wherein the fluid reservoir
further comprises an electroactive polymer actuated bi-directional
fluid pump operatively actuated by the closure actuation.
4. The surgical instrument of claim 1, wherein the pair of pivoting
members comprise cutting blades opposingly cutting tissue.
5. The surgical instrument of claim 1, wherein the pair of pivoting
members comprise grasping jaws.
6. The surgical instrument of claim 1, wherein the shaft further
comprises an articulation joint, wherein the fluid conduit further
comprises a flexible portion traversing the articulation joint.
7. The surgical instrument of claim 1, wherein the handle is
operably configured to produce a reciprocating mechanical closure
motion, the fluid reservoir selectively compressed and expanded by
the reciprocating mechanical closure motion.
8. The surgical instrument of claim 1, further comprising control
circuitry response to the closure action by the handle to
selectively produce a closure signal, the fluid reservoir further
comprising an electroactive polymer actuated bi-directional fluid
actuator.
9. The surgical instrument of claim 1, further comprising a
monitoring system operatively configured to sense an end effector
blocked condition wherein the pair of pivoting members are in a
relative position that does not correspond to a commanded
position.
10. The surgical instrument of claim 9, wherein the monitoring
system further comprises control circuitry responsive to a
comparison of a sensed commanded position and a sensed current end
effector position.
11. The surgical instrument of claim 10, wherein the monitoring
system further comprises position sensing of at least one of the
pivoting members.
12. The surgical instrument of claim 10, wherein the monitoring
system further comprises pressure sensing positioned to respond to
a fluid pressure in the fluid actuated closure mechanism.
13. A surgical instrument, comprising: a handle operably configured
to produce a bi-directional fluid motion from a handle chamber, and
to produce a longitudinal firing motion; an elongate shaft attached
to the handle and comprising a fluid conduit communicating with the
handle chamber to conduct the bi-directional fluid motion as a
fluid pressure, the elongate shaft defining a longitudinal axis
and; an end effector distally attached to the elongate shaft and
comprised of a staple channel and an anvil for clamping tissue,
wherein each of the staple channel and anvil is operably connected
to the other about a pivot to open and close the end effector and
each of the staple channel and anvil further comprises a proximal
portion extending proximal to the pivot, wherein the proximal
portion extending from the staple channel comprises a frame of the
elongate shaft attached to the handle, and the proximal portion
extending from the anvil includes a lever proximally projecting
from the pivot; a firing bar slidingly received for reciprocating
motion in the elongate shaft to transfer the longitudinal firing
motion from the handle, and distally terminating in a cutting
surface to sever the clamped tissue in the end effector; a staple
cartridge received in the staple channel and responsive to movement
of the firing bar to drive and form staples through the clamped
tissue; an outer sheath encompassing the frame of the elongate
shaft and the lever of the anvil; and a fluid actuated closure
mechanism comprising: a fluid actuator bladder positioned between
the lever and the staple channel to close the anvil, the fluid
actuator bladder in fluid communication with the fluid conduit and
proximate to the pivot and operatively coupled to at least one of
the proximal portions of the end effector to selectively open and
to close the end effector in response to the bi-directional fluid
motion from the handle chamber via the fluid pressure from the
fluid conduit which extends through the elongate shaft, wherein
when the fluid pressure from the handle chamber laterally expands
at least a portion of the fluid actuator bladder relative to the
longitudinal axis, the end effector closes, and when the fluid
pressure laterally collapses at least a portion of the fluid
actuator bladder relative to the longitudinal axis, the end
effector opens, and an opposing fluid actuator bladder positioned
between the lever extending proximally from the anvil and the outer
sheath for opposing the fluid actuator bladder positioned between
the lever and the staple channel to close the anvil, the handle
further operatively configured to differentially expand and
compress the opposing fluid actuator bladder, and the fluid
actuator bladder configured to move the anvil open and closed.
14. The surgical instrument of claim 13, wherein the handle is
operably configured to produce a reciprocating mechanical closure
motion, the handle chamber selectively compressed and expanded by
the reciprocating mechanical closure motion.
15. The surgical instrument of claim 13, further comprising control
circuitry response to the closure action by the handle to
selectively produce a closure signal, the handle chamber further
comprising an electroactive polymer actuated bi-directional fluid
pump.
16. A surgical instrument, comprising: a handle operably configured
to produce fluid motion in response to opening and closure
actuation; an elongate shaft attached to the handle and having a
longitudinal axis; first and second tissue contacting members
pivotally engaged to each other about a pivot and distally
projecting from the elongate shaft, wherein the first tissue
contacting member comprises a staple channel and the second tissue
contacting member comprises an anvil, each of said tissue
contacting members having a proximal portion extending proximally
from the pivot, wherein the proximal portion of the staple channel
comprises a frame of the elongate shaft attached to the handle, and
the proximal portion of the anvil comprises a lever extending
proximally from the pivotal engagement; a staple cartridge received
in the staple channel; a firing bar slidingly received in the
elongate channel and distally movable through the closed end
effector to effect severing and stapling of clamped tissue; an
outer sheath encompassing the frame of the elongate shaft and the
lever of the anvil; and a fluid actuated closure mechanism
comprising: a fluid actuator bladder located between and coupled
between the first and second tissue contacting members, the fluid
actuator bladder positioned proximal to the pivot and operably
engaging one or more of the proximal portion of the first and
second tissue contacting members, a fluid conduit communicating
with the fluid actuator bladder, the fluid conduit extending
through the elongate shaft, a fluid reservoir in fluid
communication with the fluid conduit and responsive to the closure
actuation of the handle, the closure motion selectively and
bi-directionally transferring fluid across the fluid conduit to
close and open the end effector by expanding and contracting at
least a portion of the fluid actuator bladder in a direction
lateral to the longitudinal axis, and an opposing fluid actuator
bladder positioned between the anvil lever and the outer sheath for
opposing the fluid actuator bladder positioned between the proximal
portions of the first and second tissue contacting members to close
the anvil, the handle further operatively configured to
differentially expand and compress the opposing fluid actuator
bladder and the fluid actuator bladder to move the anvil open and
closed.
17. The surgical instrument of claim 16, wherein the elongate shaft
includes a lever cavity receiving the lever, the fluid actuator
bladder positioned in the lever cavity.
Description
FIELD OF THE INVENTION
The present invention relates in general to surgical stapler
instruments that are capable of applying lines of staples to tissue
while cutting the tissue between those staple lines and, more
particularly, to improvements relating to stapler instruments and
improvements in processes for forming various components of such
stapler instruments.
BACKGROUND OF THE INVENTION
Surgical instruments for minimally invasive surgery are
increasingly relied upon to reduce the hospital stay and recovery
time for various surgical procedures. Many of these surgical
instruments include mechanisms that actuate an end effector via an
elongate shaft that performs a surgical step that entails two
opposing surfaces being brought into opposition to each other. For
instance, pivotally opposed jaws are used in graspers. Pivotally
attached scissor blades are incorporated into cutting devices.
Providing an actuating control down the elongate shaft with
sufficient strength is complicated by a design goal of minimum
cross sectional area so as to pass through a small cannula of a
trocar. In addition, the elongate shaft often has a plurality of
control functions (e.g., rotation, articulation, etc.) Further, it
is desirable to have reduced design complexity so as to provide an
economical device.
As an illustration of a particularly challenging surgical
instrument, surgical staplers have been used in the prior art to
simultaneously make a longitudinal incision in tissue and apply
lines of staples on opposing sides of the incision. Such
instruments commonly include a pair of cooperating jaw members
that, if the instrument is intended for endoscopic or laparoscopic
applications, are capable of passing through a cannula passageway.
One of the jaw members receives a staple cartridge having at least
two laterally spaced rows of staples. The other jaw member defines
an anvil having staple-forming pockets aligned with the rows of
staples in the cartridge. The instrument includes a plurality of
reciprocating wedges which, when driven distally, pass through
openings in the staple cartridge and engage drivers supporting the
staples to effect the firing of the staples toward the anvil.
An example of a surgical stapler suitable for endoscopic
applications, described in U.S. Pat. No. 5,465,895, advantageously
provides distinct closing and firing actions. Thereby, a clinician
is able to close the jaw members upon tissue to position the tissue
prior to firing. Once the clinician has determined that the jaw
members are properly gripping tissue, the clinician can then fire
the surgical stapler, thereby severing and stapling the tissue. The
simultaneous severing and stapling avoids complications that may
arise when performing such actions sequentially with different
surgical tools that respectively only sever or staple.
These minimally invasive surgical instruments have been widely used
and have proven to be a significant advance over traditional open
surgical techniques. It would be desirable to incorporate yet
additional features and capabilities.
BRIEF SUMMARY OF THE INVENTION
The invention overcomes the above-noted and other deficiencies of
the prior art by including a surgical instrument that is suitable
for minimally invasive surgical procedures which has a handle that
positions an end effector through a surgical opening via an
elongate shaft. The end effector has a pair of pivoting members
opposingly contacting tissue. A fluid actuated closure mechanism
responds to a closure action by a fluid actuator attached to the
handle by bi-directionally transferring fluid across a fluid
conduit to a fluid reservoir positioned to urge the pair of
pivoting members closed. Thereby, the integration of fluid conduits
within an elongate shaft allows for shafts of a desirable small
cross section which are able to perform an important surgical
operation.
In one aspect of the invention, a surgical instrument has an end
effector that is actuated by a fluid actuator to open and close
upon tissue. Once closed, a firing bar that is received for
reciprocating a longitudinal firing motion in an elongate shaft
transfers a longitudinal firing motion from a handle to actuate a
staple cartridge and to sever the clamped tissue in the end
effector.
In yet another aspect of the invention, a surgical instrument
includes a handle that produces closure actuation that transfers
fluid through a fluid conduit in an elongate shaft to a fluid
actuator positioned in a lever cavity to position a lever. The
lever of a first tissue contacting member extends proximally into
the lever cavity from a pivotal connection with a second tissue
contacting member. Fluid transfer advantageously effects pivotal
movement of the pair of tissue contacting members.
These and other objects and advantages of the present invention
shall be made apparent from the accompanying drawings and the
description thereof.
BRIEF DESCRIPTION OF THE FIGURES
The accompanying drawings, which are incorporated in and constitute
a part of this specification, illustrate embodiments of the
invention, and, together with the general description of the
invention given above, and the detailed description of the
embodiments given below, serve to explain the principles of the
present invention.
FIG. 1 is a perspective view of a surgical stapling and severing
instrument having a fluid actuated upper jaw (anvil) in an open
position and an electroactive polymer (EAP) medical substance
dispensing shaft.
FIG. 2 is a disassembled perspective view of an implement portion
of the surgical stapling and severing instrument of FIG. 1.
FIG. 3 is left side view in a elevation of the implement portion of
the surgical stapling and severing instrument of FIG. 1 taken in
cross section generally through a longitudinal axis and passing
through an offset EAP syringe and receptacle that is in fluid
communication with a dispensing groove in an E-beam firing bar.
FIG. 4 is a left side detail view in elevation of a distal portion
of the implement portion of the surgical stapling and severing
instrument of FIG. 1 taken in cross section generally through the
longitudinal axis thereof but showing a laterally offset fluid
actuator bladder actuator opening the anvil.
FIG. 5 is a left side detail view of an E-beam firing bar
incorporating medical substance ducting.
FIG. 6 is a left side detail view in elevation of the distal
portion of the implement portion of the surgical stapling and
severing instrument of FIG. 4 taken in cross section generally
through the longitudinal axis thereof with the anvil closed.
FIG. 7 is a left side detail view of the E-beam firing bar of FIG.
6.
FIG. 8 is a top detail view of a joined portion of a lower jaw
(staple channel) of the end effector and elongate shaft taken in
cross section through the lines 8-8 depicting guidance to the
E-beam firing bar.
FIG. 9 is a front view of a firing bar guide of the implement
portion of the surgical stapling and severing instrument of FIG.
2.
FIG. 10 is a left side view of the firing bar guide of FIG. 9 taken
in cross section along lines 9-9.
FIG. 11 is a front view in elevation of the elongate shaft of the
surgical stapling and severing instrument of FIG. 3 taken along
lines 11-11 taken through a distal end of the EAP medical substance
syringe.
FIG. 12 is a left side view of the EAP medical substance syringe of
FIG. 11.
FIG. 13 is a left side view of the implement portion of the
surgical stapling and severing instrument of FIG. 1 partially cut
away to show proximal mountings for the EAP medical substance
syringe.
FIG. 14 is a left side detail view of the EAP medical substance
syringe and receptacle of the elongate shaft of the surgical
stapling and severing instrument of FIG. 13.
FIG. 15 is a top view of the firing bar of the surgical stapling
and severing instrument of FIG. 2.
FIG. 16 is a left side view of a laminate firing bar showing an
internal fluid path in phantom for the surgical stapling and
severing instrument of FIG. 1.
FIG. 17 is a left side detail view of an alternate E-beam showing
an internal fluid path in phantom showing an internal fluid path in
phantom.
FIG. 18 is a front view in elevation of the laminate firing bar of
FIG. 15 taken in cross section along line 18-18 through a proximal
open groove of a fluid path.
FIG. 19 is a left side view of an alternative surgical stapling and
severing instrument of FIG. 1 partially cut away and depicting
control circuitry and controls.
FIG. 20 is a flow diagram of a sequence of operations performed by
control circuitry of the surgical stapling and severing instrument
of FIG. 19.
FIG. 21 is an enlarged left side detail view of an end effector
with a pair of pivoting members in a scissors like arrangement.
FIG. 22 is a cross sectional left side view of a portion of the
instrument of FIG. 4 with an opposing lifting bag.
DETAILED DESCRIPTION OF THE INVENTION
Turning to the Drawings, wherein like numerals denote like
components throughout the several views, FIGS. 1-2 show a surgical
stapling and severing instrument 10 that is capable of practicing
the unique benefits of the present invention, including both fluid
actuation (e.g., opening, closing/clamping) of an upper jaw (anvil)
12 of an end effector 14 as well as dispensing a medical substance
onto tissue as severed. Fluid actuation of the end effector 14
provides a range of design options that avoid some design
limitations of traditional mechanical linkages. For example,
instances of binding or component failure may be avoided. Further,
dispensing liquids onto severed tissue allows for a range of
advantageous therapeutic treatments to be applied, such as the
application of anesthetics, adhesives, cauterizing substances,
antibiotics, coagulant, etc.
With particular reference to FIG. 2, the surgical stapling and
severing instrument 10 includes an implement portion 16 formed by
an elongate shaft 18 and an end effector 14, depicted as a stapling
assembly 20. The surgical stapling and severing instrument 10 also
includes a handle 22 (FIG. 1) attached proximally to the shaft 18.
The handle 22 remains external to the patient as the implement
portion 16 is inserted through a surgical opening, or especially a
cannula of a trocar that forms a pneumoperitoneum for performing a
minimally invasive surgical procedure.
Left and right fluid actuator bladders (lift bags) 24, 26 are
supported within an aft portion 28 of a staple channel 30. The
anvil 12 includes a pair of inwardly directed lateral pivot pins
32, 34 that pivotally engage outwardly open lateral pivot recesses
36, 38 formed in the staple channel 30 distal to the aft portion
28. The anvil 12 includes a proximally directed lever tray 40 that
projects into the aft portion 28 of the staple channel 30 overtop
and in contact with the fluid actuator bladders (lift bags) 24, 26
such that filling the fluid actuator bladders 24, 26 causes a
distal clamping section 41 of the anvil 12 to pivot like a
teeter-totter toward a staple cartridge 42 held in an distal
portion 44 of the staple channel 30. Evacuation and collapse of the
fluid actuator bladders 24, 26, or some other resilient feature of
the end effector 14, causes the anvil 12 to open. Left and right
fluid conduits 46, 48 communicate respectively with the left and
right fluid actuator bladders 24, 26 to bi-directionally transfer
fluid for actuation.
It will be appreciated that the terms "proximal" and "distal" are
used herein with reference to a clinician gripping a handle of an
instrument. Thus, the staple applying assembly 20 is distal with
respect to the more proximal handle 22. It will be further
appreciated that, for convenience and clarity, spatial terms such
as "vertical" and "horizontal" are used herein with respect to the
drawings. However, surgical instruments are used in many
orientations and positions, and these terms are not intended to be
limiting and absolute.
The elongate shaft 18 includes a frame 50 (FIG. 2) whose proximal
end is rotatably engaged to the handle 22 such that a rotation knob
52 rotates the frame 50 along with the end effector 14. A distal
end of the frame has lateral recesses 54 that engage a distal lip
56 of the staple channel 30. The frame 50 includes a laterally
centered, bottom firing slot 58 that passes longitudinally through
the frame 50 for receiving a two-piece firing bar 60 comprised of a
firing bar 62 with a distally attached E-beam 64, the latter
translating within the staple applying assembly 20 to sever and
staple tissue. A distal portion of the frame 50 includes an upper
cavity 66 whose distal and proximal ends communicate through distal
and proximal apertures 68, 70, defining there between a cross bar
72 over which a distally projecting clip 74 of a clip spring 76
engages with a lower spring arm 78, distally and downwardly
projecting through the upper cavity 66 to bias the firing bar 62
downwardly into engagement with the staple channel 30, especially
when the lower spring arm 78 encounters a raised portion 80 on the
firing bar 62.
Medical substance dispensing is integrated into the elongate shaft
18 by including a laterally offset cylindrical cavity 90 formed in
the frame 50 that communicates along its longitudinal length to the
outside via a rectangular aperture 92 that is slightly shorter than
an electroactive polymer (EAP) syringe 100 that is inserted through
the aperture 92 into the cylindrical cavity 90. A proximal portion
of the cylindrical cavity 90 contains a longitudinally aligned
compression spring 102 that urges a distal dispensing cone 104 of
the EAP syringe 100 distally into sealing contact with the frame 50
and allows translation for insertion and removal of the EAP syringe
100. An electrical conductor 106 passes through the frame 50 and is
attached to the compression spring 102, which is also formed of an
electrically conductive metal. An aft portion of the EAP syringe is
conductive and contacts the spring 102 to form a cathode to an EAP
actuator 110 held in a proximal portion of the EAP syringe 100. It
will be appreciated that another conductor, perhaps traveling with
the conductor 106, also electrically communicates to the EAP
actuator 110 to serve as the anode.
When activated, the EAP actuator 110 longitudinally expands,
serving as a plunger to dispel a medical substance 112 in a distal
portion of the EAP syringe 100 through the distal dispensing cone
104. Insofar as the EAP actuator 110 laterally contracts to
compensate for its longitudinal expansion, a plunger seal 114
maintains a transverse seal within the EAP syringe 100. A vent (not
shown), such as around conductor 106 allows air to refill the EAP
syringe 100 as the medical substance 112 is dispensed. The vent may
rely upon the surface tension of the medical substance 112 to
prevent leaking. Alternatively, a one-way valve may be used for the
same purpose. As described below, the medical substance 112 is
conducted by the frame 50 to a lateral fluid groove 120 that is
formed in the firing bar 62 and the E-beam 64 to direct the medical
substance to a cutting surface 122 of the E-beam 64. The frame slot
58 is sized to seal the lateral fluid groove 120. The portion of
the lateral fluid groove 120 that is positioned under the spring
clip 76 is sealed by a firing bar guide 124. In the illustrative
version, an outer sheath 130 encompasses the frame 50 and
proximally projecting lever tray 40 of the anvil 12. A top distal
opening 131 allows closing of the anvil 12.
An outer rectangular aperture 132 of the outer sheath 130 is sized
and longitudinally positioned to correspond to the rectangular
aperture 92 formed in the frame 50. In some applications, the outer
sheath 130 may be rotated to selectively align the rectangular
aperture 92 with the outer rectangular aperture 132 for insertion
or removal of the EAP syringe 100. It should be appreciated that in
some applications the EAP syringe 100 may be integrally assembled
into an elongate shaft that does not allow for selecting a desired
medical substance. For instance, a disposable implement portion
with an integral staple cartridge and medical dispensing reservoir
may be selected by the clinician as a unit. It is believed that
allowing insertion at the time of use, though, has certain
advantages including clinical flexibility in selecting a medical
substance (e.g., anesthetics, adhesives, antibiotics, cauterizing
compound, etc.) and extending the shelf life/simplifying storage
and packaging of the implement portion 16.
In the illustrative version, an elongate stack of many disk-shaped
EAP layers are aligned longitudinally and configured to expand
along this longitudinal axis. Electroactive polymers (EAPs) are a
set of conductive doped polymers that change shape when electrical
voltage is applied. In essence, the conductive polymer is paired to
some form of ionic fluid or gel and electrodes. Flow of the ions
from the fluid/gel into or out of the conductive polymer is induced
by the voltage potential applied and this flow induces the shape
change of the polymer. The voltage potential ranges from 1V to 4
kV, depending on the polymer and ionic fluid used. Some of the EAPs
contract when voltage is applied and some expand. The EAPs may be
paired to mechanical means such as springs or flexible plates to
change the effect that is caused when the voltage is applied.
There are two basic types of EAPs and multiple configurations of
each type. The two basic types are a fiber bundle and a laminate
version. The fiber bundle consists of fibers around 30-50 microns.
These fibers may be woven into a bundle much like textiles and are
often called EAP yarn because of this. This type of EAP contracts
when voltage is applied. The electrodes are usually made up of a
central wire core and a conductive outer sheath that also serves to
contain the ionic fluid that surrounds the fiber bundles. An
example of a commercially available fiber EAP material,
manufactured by Santa Fe Science and Technology and sold as
PANION.TM. fiber, is described in U.S. Pat. No. 6,667,825, which is
hereby incorporated by reference in its entirety.
The other type is a laminate structure, which consists of a layer
of EAP polymer, a layer of ionic gel and two flexible plates that
are attached to either side of the laminate. When a voltage is
applied, the square laminate plate expands in one direction and
contracts in the perpendicular direction. An example of a
commercially available laminate (plate) EAP material is
manufactured by Artificial Muscle Inc, a division of SRI
Laboratories. Plate EAP material is manufactured by EAMEX of Japan
and is referred to as thin film EAP.
It should be noted that EAPs do not change volume when energized;
they merely expand or contract in one direction while doing the
opposite in the transverse direction. The laminate version may be
used in its basic form by containing one side against a rigid
structure and using the other much like a piston. The laminate
version may also be adhered to either side of a flexible plate.
When one side of the flexible plate EAP is energized, it expands,
flexing the plate in the opposite direction. This allows the plate
to be flexed in either direction, depending on which side is
energized.
An EAP actuator usually consists of numerous layers or fibers
bundled together to work in cooperation. The mechanical
configuration of the EAP determines the EAP actuator and its
capabilities for motion. The EAP may be formed into long stands and
wrapped around a single central electrode. A flexible exterior
outer sleeve will form the other electrode for the actuator as well
as contain the ionic fluid necessary for the function of the
device. In this configuration when the electrical field is applied
to the electrodes, the strands of EAP shorten. This configuration
of EAP actuator is called a fiber EAP actuator. Likewise, the
laminate configuration may be placed in numerous layers on either
side of a flexible plate or merely in layers on itself to increase
its capabilities. Typical fiber structures have an effective strain
of 2-4% where the typical laminate version achieves 20-30%,
utilizing much higher voltages.
For instance, a laminate EAP composite may be formed from a
positive plate electrode layer attached to an EAP layer, which in
turn is attached to an ionic cell layer, which in turn is attached
to a negative plate electrode layer. A plurality of laminate EAP
composites may be affixed in a stack by adhesive layers there
between to form an EAP plate actuator. It should be appreciated
that opposing EAP actuators may be formed that can selectively bend
in either direction.
A contracting EAP fiber actuator may include a longitudinal
platinum cathode wire that passes through an insulative polymer
proximal end cap through an elongate cylindrical cavity formed
within a plastic cylinder wall that is conductively doped to serve
as a positive anode. A distal end of the platinum cathode wire is
embedded into an insulative polymer distal end cap. A plurality of
contracting polymer fibers are arranged parallel with and
surrounding the cathode wire and have their ends embedded into
respective end caps. The plastic cylinder wall is peripherally
attached around respective end caps to enclose the cylindrical
cavity to seal in ionic fluid or gel that fills the space between
contracting polymer fibers and cathode wire. When a voltage is
applied across the plastic cylinder wall (anode) and cathode wire,
ionic fluid enters the contracting polymer fibers, causing their
outer diameter to swell with a corresponding contraction in length,
thereby drawing the end caps toward one another.
Additional description of applications of EAP actuators in a
surgical instrument are described in commonly-owned U.S. patent
application Ser. No. 11/082,495 filed on 17 Mar. 2005, and entitled
"SURGICAL INSTRUMENT INCORPORATING AN ELECTRICALLY ACTUATED
ARTICULATION MECHANISM", the disclosure of which is hereby
incorporated by reference in its entirety.
Returning to FIG. 1, the handle 22 controls closure of the anvil
12, firing of the two-piece firing bar 60, and dispensing of the
medical substance. In an illustrative version, a pistol grip 140
may be grasped and a thumb button 142 depressed as desired to
control closure of the anvil 12. The thumb button 142 provides a
proportional electrical signal to an EAP dispensing actuator (not
shown) similar to the EAP syringe 100 to transfer fluid through the
conduits 46, 48 to the fluid actuator bladders 24, 26 to close the
anvil 12 (FIG. 2). When the thumb button 142 is fully depressed, a
mechanical toggle lock (not shown) engages to hold the thumb button
142 down until a full depression releases the toggle lock for
releasing the thumb button 142. Thus, when the thumb button 142 is
held down, the surgeon has a visual indication that the end
effector 14 is closed and clamped, and they may be maintained in
this position by continued activation of an EAP dispensing actuator
or by a locking feature. For instance, control circuitry may sense
movement of the thumb button 142, causing a normally closed EAP
shutoff valve (not shown) to open that communicates between the EAP
dispensing actuator and the conduits 46, 48. Once movement ceases,
the EAP shutoff valve is allowed to close again, maintaining the
anvil 12 position. In addition, a manual release could be
incorporated to defeat such a lockout to open the anvil 12.
As an alternative, a closure trigger (not shown) or other actuator
may be included that bi-directionally transfers fluid to the fluid
actuator bladders 24, 26. In the above-referenced patent
application Ser. No. 11/061,908, a number of such fluid actuators
for articulation of a pivoting shaft are described that may be
adapted for closing the anvil 12. To take full advantage of the
differential fluid transfer described for several of these
versions, it should be appreciated that an opposing lift bag 555 as
shown in FIG. 22 may be placed above the lever tray 40 of the anvil
12 to assert an opening force as the left and right fluid actuator
bladders (lift bags) 24, 26 collapse.
To avoid undesirable firing situations, sensing may be
advantageously incorporated into the control circuitry. For
instance, a pressure transducer and/or position sensing may be
positioned to monitor the fluid transfer and/or anvil position. For
instance, the proximity of the anvil to the 12 to the staple
channel 30 may be sensed and firing locked out if not closed.
Monitoring may detect a fluid pressure exceeding a threshold
indicating that anvil 12 commanded closed with something preventing
this closing (e.g., excessive tissue in the end effector 14).
Similarly, a fluid pressure below a lower threshold with anvil 12
commanded open may indicate an inability for the anvil 12 to open
(e.g., abutting tissue). Colored light emitting diodes (LEDs) (not
shown) on the handle 22 may give an indication to the surgeon by
color, flashing, etc. These indications may include POWER ON,
Self-Test GOOD, Self-Test BAD, BATTERY LOW, ANVIL OPEN, ANVIL
CLOSED, ANVIL BLOCKED OPEN, ANVIL BLOCK CLOSED. An indication that
would warrant precluding firing may be used to disable firing.
With particular reference to FIG. 3, the handle 22 includes a
firing trigger 150 (FIG. 1) that is drawn proximally toward the
pistol grip 140 to cause a firing rod 152 to move distally in a
proximal portion 154 of the elongate shaft 18. A distal bracket 156
of the firing rod 152 engages an upward proximal hook 158 of the
firing bar 62. A dynamic seal 160 within the frame 50 seals to the
firing rod 152 so that the implement portion is pneumatically
sealed when inserted into an insufflated abdomen.
An anti-backup mechanism 170 of the firing rod 152 may be
advantageously included for a handle 22 that includes a multiple
stroke firing trigger 150 and a retraction biased firing mechanism
coupled to the firing rod 152 (not shown). In particular, an
anti-backup locking plate 172 has the firing rod 152 pass through a
closely fitting through hole (not shown) that binds when a
retracting firing rod 152 tips the lock plate 172 backward as shown
with the bottom of the locking plate held in position within the
frame 50. An anti-backup cam sleeve 174 is positioned distal to the
anti-backup locking plate 172 and urged into contact by a more
distal compression spring 176 through which the firing rod 152
passes and that is compressed within the frame 50. It should be
appreciated that mechanisms in the handle 22 may manually release
the anti-backup mechanism 170 for retraction of the firing rod
152.
In FIGS. 4-5, the end effector 14, which in the illustrative
version is a staple applying assembly 20, is opened by having fluid
actuator bladder 24 deflated, drawing down lever tray 40 of the
anvil 12, which pivots about pin 32 raising distal clamping section
41 thereby allowing positioning body tissue 180 between the anvil
12 and staple cartridge 42. The E-beam 64 has an upper pin 182 that
resides within an anvil pocket 184 allowing repeated opening and
closing of the anvil 12. An anvil slot 186, formed along the length
of the anvil 12, receives the upper pin 182 when the anvil 12 is
closed and the two piece firing bar 60 is distally advanced. A
middle pin 188 slides within the staple cartridge 42 above the
staple channel 30 in opposition to a bottom pin or foot 190 that
slides along a bottom surface of the staple channel 30.
In FIGS. 6-7, the staple applying assembly 20 has been closed by
expanding the fluid actuator bladder (lift bag) 24, raising the
lever tray 40 of the anvil 12 until flush with the outer sheath
130, with a proximal upwardly bent tip 192 of the lever tray 40
allowed to enter the top distal opening 131. This bent tip 192, in
combination with the opening 131, advantageously allows greater
radial travel for the anvil 12 as well as presenting an abutting
surface rather than a piercing tip to the underlying fluid actuator
bladder 24. When the anvil 12 is closed, the upper pin 182 is
aligned with the anvil slot 186 for firing and the tissue 180 is
flattened to a thickness appropriate for severing and stapling.
In FIGS. 7-8, the E-beam 64 is cut away to show its bottom foot 190
riding along a downwardly open laterally widened recess 200 that
communicates with a narrow longitudinal slot 202 through which a
vertical portion 204 of the E-beam 64 passes. A proximal aperture
206 to the narrow longitudinal slot 202 allows an assembly entrance
for the lower foot 190. A bottom bump 208 is positioned on the
firing bar 62 to drop into the proximal aperture 206 during an
initial portion of firing travel under the urging of the clip
spring 76 against the upper portion 80 of the firing bar 62 for
proper engagement and for possible interaction with an end effector
firing lockout mechanism (not shown). Also, this position allows
for the end effector 14 to be pinched shut to facilitate insertion
through a surgical entry point such as a cannula of a trocar (not
shown). With reference to FIGS. 8-10, the firing bar guide 124
laterally contacts a portion of the firing bar 62 to close the
corresponding portion of the lateral fluid groove 120. In FIG. 11,
the EAP syringe 100 in the cylindrical cavity 90 has its distal
dispensing cone 104 communicating with a radial fluid passage 220
formed in the frame 50 that communicates in turn with the lateral
fluid groove 120. In FIG. 12, before installation in the surgical
stapling and severing instrument 10, the EAP syringe 100 may be
advantageously sealed with a disposable cap 230. In FIGS. 13-14,
the EAP syringe 100 is shown without the disposable cap 230 and
urged by spring 230 distally to engage the distal dispensing cone
104 into communication with the radial fluid passage 220.
It should be appreciated that one or more sensor in the surgical
stapling and severing instrument 10 may sense a firing condition
(e.g., movement of firing bar or mechanism coupled to the firing
bar, position of the firing trigger, a separate user control to
dispense, etc.) and activate dispensing control circuitry to effect
dispensing.
In FIGS. 15-18, an alternate two-piece firing bar 300 is formed
from longitudinally laminated left half and right half firing bar
portions 302, 304 that form a firing bar 305 attached to an E-beam
309. Thereby, fluid transfer down the firing bar 300 may be further
constrained. In particular, a left side fluid groove 310 in the
left half firing bar portion 302 transitions distally to a pair of
aligned internal fluid grooves 312, 314 respectively in the left
and right half firing bar portions 302, 304, defining an internal
fluid passage 316. Since the E-beam 309 is laterally thicker and of
short longitudinal length, a drilled fluid passage 320 is formed
therein between a cutting surface 322 and an aft edge aligned to
communicate with the internal fluid passage 316.
In FIG. 19, an alternate surgical stapling and severing instrument
410 that is capable of practicing the unique benefits of the
present invention, including both fluid actuation (e.g., opening,
closing/clamping) of an upper jaw (anvil) 412 of an end effector
414 as well as dispensing a medical substance onto tissue as
severed. An implement portion 416 is formed by an elongate shaft
418 and the end effector 414, depicted as a stapling assembly 420.
The surgical stapling and severing instrument 410 also includes a
handle 422 attached proximally to the shaft 418. The handle 422
remains external to the patient as the implement portion 416 is
inserted through a surgical opening, or especially a cannula of a
trocar that forms a pneumoperitoneum for performing a minimally
invasive surgical procedure.
A fluid actuator bladders (lift bag) 424 is supported within a
staple channel 430 beneath a proximally directed lever 440 that
projects such that filling the fluid actuator bladder 424, 26
causes the anvil 412 to pivot like a teeter-totter toward a staple
cartridge 442 held in an distal portion 444 of the staple channel
430. Evacuation and collapse of the fluid actuator bladder 424 is
assisted by a resilient pressure transducer 425 positioned above
the anvil lever 440 in opposition to the fluid actuator bladder
424, urging fluid to flow proximally through a fluid conduit
446.
Control circuitry 450 is powered when enabled by an ON/OFF switch
452 to electrically connect batteries 454 that are physically
accessed via a battery cap 456 that closes a battery compartment
457 in a pistol grip 458 of the handle 422. A controller (e.g.,
microcontroller, programmed logic array, analog control circuit,
etc.) 460 receives electrical signals from switches that are
actuated by a user or from sensors that indicate a state of the
instrument 410. For instance, a thumb button pressure sensor 462
contacting a thumb button 464 senses a closure command. This
closure command signal may be a discrete open/close signal or a
more continuous value indicating intermediate degrees of closure.
Alternatively, the controller 460 may sense a first depression of
the thumb button 464 to close and sense a second depression of the
thumb button 464 to then open.
The controller 460 responds to the closure signal by activating an
electrical fluid control, which in the illustrative version is an
EAP syringe actuator 470 containing an EAP stack actuator 472 that
translates a plunger 474 within a cylinder 476 to dispense fluid
through the fluid conduit 446. The cylinder 476 may be
advantageously sized to produce a desired fluid flow rate at a
desired fluid pressure to effect closure without excessive pressure
if too much tissue is grasped.
The pressure of the fluid may be advantageously sensed by a fluid
pressure transducer 478 attached to the cylinder 476 and/or by
sensing movement of the anvil 412 from the resilient pressure
transducer 425. Alternatively or in addition, fluid volume
transferred may be advantageously sensed, such as by Hall effect
transducers 480, 482 attached to the cylinder 476 to sense a target
incorporated into the plunger 474. The controller 460 may provide
indications to the surgeon via an alphanumeric display (not shown)
or via a plurality of LEDs, such as a POWER LED 490, an ANVIL
POSITION LED 492, and FAULT LED 494. The controller 460 may also
sense firing, such as a trigger sensor 496, and in response thereto
command the EAP medical substance dispenser 100 to dispense.
In use, as depicted in FIG. 20, an end effector closure and
dispensing control procedure, or sequence of operations, 500 is
performed by the control circuitry 460 of FIG. 19. In response to
power being supplied (block 502), the POWER LED is illuminated
(FIG. 504). A determination is made as to whether a close command
has been sensed (block 506). If not, a CLOSED LED is extinguished
(if lit) (block 508). The closure actuator is deactivated (if
currently activated) to allow resilient opening of the anvil (block
510). Firing is disabled (FIG. 512) and processing loops back to
block 504 to continue waiting for a close command. If a close
command is sensed in block 506, then the closure actuator is
activated (block 514) and a predetermined time elapses waiting for
the anvil to respond (block 516). Then a determination is made in
block 518 as to whether successful closing has occurred, such as by
comparing a pressure profile or by sensing a position (e.g., anvil,
anvil). If not satisfied, then the FAULT LED is illuminated (block
520). The closure actuator is deactivated (block 522) and
processing stops (block 524). User intervention may require cycling
of power to reset the device. If in block 518 the anvil was
successfully closed, then the CLOSED LED is illuminated (block
526). The closure actuator is maintained in this closed condition
(block 528), which may be assisted by a clamping lock that allows
deactivating the closure actuator. Firing is enabled (block 530).
Then a determination is made as to whether the close command is
still present (block 532). If not, processing loops back to block
504 to open the end effector. If still closed in block 532, then a
further determination is made as to whether firing of the end
effector is sensed (block 534). If so, medical substance dispensing
is activated (block 536). Else, processing loops back to block 532
to continue waiting for firing.
While the present invention has been illustrated by description of
several embodiments and while the illustrative embodiments have
been described in considerable detail, it is not the intention of
the applicant to restrict or in any way limit the scope of the
appended claims to such detail. Additional advantages and
modifications may readily appear to those skilled in the art.
For example, while a non-articulating shaft is described herein for
clarity, it should be appreciated that fluid actuated end effector
and/or medical substance dispensing may be incorporated into an
articulating shaft. In particular, flexible fluid conduits may be
incorporated that pass through an articulation joint of a shaft.
Alternatively, passages may be formed in a flex-neck type
articulation joint to transfer fluid there through.
As another example, while both medical substance dispensing and
fluid actuated anvil closing are illustrated herein, applications
consistent with aspects of the invention may include either of
these features. Further, for applications in which an adhesive
and/or cauterizing medical substance is dispensed, it should be
appreciated that features such as staples may be omitted.
As another example, while a staple applying assembly 20 is
illustrated herein, it should be appreciated that other end
effectors (graspers, cutting devices, etc.) may benefit from either
or both of fluid controlled closing and medical substance
dispensing.
As yet another example, a receptacle for the EAP syringe may be
formed in the handle rather than in the elongate shaft.
While an electroactive polymer plunger has various advantages, it
should be appreciated that other types of electrically actuated
devices may be employed to dispense a medical substance through the
elongate shaft to the end effector.
As yet an additional example, a symmetric arrangement for a second
EAP syringe may be formed in the elongate channel so that two
medical substances may be simultaneously dispensed during
firing.
As yet a further example, while a staple applying apparatus
provides an illustrative embodiment, it should be appreciated that
other endoscopic instruments may benefit from the ability to
dispense a liquid at or near a distal end thereof. Examples of
instruments that may benefit include, but are not limited to, an
ablation device, a grasper, a cauterizing tool, an anastomotic ring
introduction device, a surgical stapler, a linear stapler, etc. As
such, those instruments that do not employ a firing bar that serves
herein as a convenient fluid passage to a cutting surface may
instead incorporate ducting or fluid conduits to an appropriate
location.
While an electroactive polymer plunger has various advantages, it
should be appreciated that other types of electrically actuated
devices may be employed to dispense a medical substance through the
elongate shaft to the end effector.
As yet an additional example, a fluid actuator bladder that is
constrained within a recess of the elongate shaft may be
substituted with a cylinder and piston ram.
It should be appreciated that in some applications consistent with
the invention, both pivoting members 501, 502 of an end effector
500 pivot with respect to a distal end 505 of the end effector 510
in a scissor-like arrangement as shown in FIG. 21. Thus, a fluid
actuator bladder 515 may be positioned to assert a force to
separate or to draw together respective levers 520, 522 proximally
projecting from a pivoting connection 530 of these pivoting members
500, 502 to effect closure (e.g., grasping, cutting) or
opening.
As an alternative, it should be appreciated that a fluid actuator
bladder may be positioned distal to the pivotal engagement between
opposing jaws to urge the jaws open.
As another example, although a handle 22 for direct manipulation by
a surgeon is depicted for clarity, a robotically positioned
instrument consistent with aspects of the invention may
advantageously take advantage of the electrical control and sensing
with fluid transfer actuation as described herein.
* * * * *